NCT02689648

Brief Summary

Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more about symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases for a follow up using a validated questionnaire and analyse the long term prognosis and risk factors for prolonged severe symptoms.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Feb 2016Jan 2027

Study Start

First participant enrolled

February 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

8.9 years

First QC Date

February 8, 2016

Last Update Submit

May 15, 2024

Conditions

Functional Gastrointestinal Disorder

Outcome Measures

Primary Outcomes (1)

  • Percentage (%) of patients that fulfill the ROME-III criteria for FGID

    Measured by the validated ROME-III questionnaire

    5 years after fist visit +/- 1 year

Secondary Outcomes (3)

  • ICD 10-diagnosis following the primary investigation

    12 months after first visit

  • Current ICD 10-diagnosis

    5 years after fist visit +/- 1 year

  • Number (n) of visits for the primary investigations

    0-12 months after first visit

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All children between 3 and 18 years of age that were refereed to the Pediatric Clinic of Västerbotten county council during the years 2009-2015.

At time of first visit the children had: 1. At least 2 months of abdominal pain 2. Age 3-18 years 3. No organic gastrointestinal diseases 4. No neuromuscular disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Umeå University, Department of Clinical Sciences

Umeå, 90185, Sweden

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Staffan K Berglund

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 24, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)